Study to Examine Safety, Tolerability and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00785408
First received: November 4, 2008
Last updated: June 4, 2014
Last verified: September 2013
  Purpose

A randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to examine the safety, tolerability, and effect on body weight of subcutaneous AC2307 in obese or overweight subjects.


Condition Intervention Phase
Obesity
Overweight
Drug: AC2307
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study to Examine the Safety, Tolerability, and Effect on Body Weight of Subcutaneous AC2307 in Obese or Overweight Subjects

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To examine the effect on body weight of AC2307 injected subcutaneously (SC) twice daily (BID) in obese or overweight subjects [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of AC2307 injected SC BID in obese or overweight subjects [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the effect of AC2307 injected SC BID in obese or overweight subjects on the following parameters: waist circumference; gastric emptying rate; fasting circulating metabolic parameters; patient reported outcomes [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • To examine the pharmacokinetics of AC2307 injected SC BID in obese or overweight subjects [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 273
Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: AC2307
subcutaneous, twice daily, low dose
Experimental: 2 Drug: AC2307
subcutaneous, twice daily, middle dose
Experimental: 3 Drug: AC2307
subcutaneous, twice daily, high dose
Placebo Comparator: 4 Drug: placebo
subcutaneous, twice daily, low dose
Placebo Comparator: 5 Drug: placebo
subcutaneous, twice daily, middle dose
Placebo Comparator: 6 Drug: placebo
subcutaneous, twice daily, high dose

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Is obese with a body mass index (BMI) ≥30 kg/m^2 to ≤45 kg/m^2, or is overweight with a BMI ≥27 kg/m^2 to <30 kg/m^2 and has at least one weight-related comorbidity (dyslipidemia, impaired fasting glucose, hypertension, obstructive sleep apnea syndrome, polycystic ovary syndrome, and/or osteoarthritis)

Exclusion Criteria:

  • Has had a major change in daily physical activity (e.g., initiation of an exercise program) or has been enrolled in a weight loss program within 2 months prior to study start
  • Has received AC2307 or pramlintide in a clinical study or has received prior treatment with pramlintide (SYMLIN®) or calcitonin
  • Has received any investigational drug within 1 month or within a period corresponding to five times the half-life of the investigational drug, whichever is greater, before study start
  • Has donated blood within 2 months before study start or is planning to donate blood during the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785408

Locations
United States, Alabama
Research Site
Birmingham, Alabama, United States
United States, Arizona
Research Site
Chandler, Arizona, United States
United States, California
Research Site
Santa Rosa, California, United States
Research Site
Walnut Creek, California, United States
United States, Colorado
Research Site
Denver, Colorado, United States
United States, Florida
Research Site
Jacksonville, Florida, United States
Research Site
Miami, Florida, United States
United States, Illinois
Research Site
Chicago, Illinois, United States
United States, Kansas
Research Site
Overland Park, Kansas, United States
United States, Louisiana
Research Site
Baton Rouge, Louisiana, United States
United States, Montana
Research Site
Butte, Montana, United States
United States, Ohio
Research Site
Cincinnati, Ohio, United States
United States, Oregon
Research Site
Eugene, Oregon, United States
Research Site
Medford, Oregon, United States
United States, South Carolina
Research Site
Greer, South Carolina, United States
Research Site
Mt. Pleasant, South Carolina, United States
United States, Texas
Research Site
Austin, Texas, United States
United States, Washington
Research Site
Olympia, Washington, United States
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Hubert Chen, MD Amylin Pharmaceuticals, LLC.
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00785408     History of Changes
Other Study ID Numbers: CFA104
Study First Received: November 4, 2008
Last Updated: June 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
obesity
overweight
weight loss
Amylin
AC2307

Additional relevant MeSH terms:
Body Weight
Obesity
Overweight
Nutrition Disorders
Overnutrition
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014